CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 400 target
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00514280
NCT00514280N/ACompleted

Tobacco Smoke and Lead Exposure During Pregnancy: Intervention to Reduce Effects on Birth-Weight and Gestational Age

In Brief

An observational study for Lead Exposure in Pregnant Women and Tobacco Smoke Exposure Pregnant Women. Completed, enrolled 400 participants across 1 site.

Detailed Summary

This study will test whether a short interview session about lead and secondhand tobacco smoke can help pregnant women reduce their exposure to lead and secondhand smoke. Both lead and secondhand tobacco smoke can cause problems with a pregnancy. The best way to prevent exposure to lead and secondhand tobacco smoke is to recognize the sources and avoid them. Non-smoking African-American and Hispanic pregnant women between 18 and 49 years of age who live in Washington, D.C. may be eligible for this study. Participants are randomly assigned to one of two study groups. Both groups have a 30-minute one-on-one session with a member of the study staff. The content of the session differs between groups. In addition, all women undergo the following tests and procedures: * Answer questions about themselves, their pregnancies, diet, home and smokers in the home. * Requested to provide permission to obtain medical records of children older than 12 months of age who have ever been seen at Children's National Medical Center. * Blood draws at least four times during the study: at the time of enrollment, during the second trimester of the pregnancy, during the third trimester, and at the time of delivery. Up to three optional blood samples may also be requested, one during each trimester of the pregnancy. Blood samples are used to measure lead, cotinine (a chemical the body makes out of nicotine) and hematocrit (a test for anemia). * Collection of umbilical cord blood at the time of delivery. * Answer questions after the delivery about the patient's health, the delivery and the baby.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 9, 2007
Enrollment StartAug 2, 2007
Study CompletionMay 11, 2011
TodayJul 2, 2026
Posted 18.9 years ago